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Cinobufotalin intraperitoneal treatment of malignant ascites

Clinical studies cinobufacini injection intraperitoneal treatment of advanced gastrointestinal cancer malignant ascites

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15005907
Enrollment
Unknown
Registered
2015-01-20
Start date
2015-02-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced gastrointestinal malignant ascites

Interventions

Experimental:Cinobufacini intraperitoneal injection
Control:5 -fluorouracil intraperitoneal injection

Sponsors

Dongfang Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) In line with advanced gastrointestinal diagnostic criteria for malignant ascites; (2) Age 18-80 years old; (3) 2 weeks is not systemic chemotherapy, peritoneal perfusion therapy; (4) 2 weeks of unused cinobufotalin preparations; (5) ECOG performance status score 0-3 points; (6) In determining the amount of ascites above grade level II peritoneal effusion, ascites amount 1000-3000ml; (7) Volunteered to participate and signed informed consent.

Exclusion criteria

Exclusion criteria: Patient compliance with any one of the following exclusion criteria are not enrolled in trials: (1) ascites non-neoplastic causes of cirrhosis of the liver, peritonitis, and hypoalbuminemia; (2) for toad allergies or adverse reactions arrhythmia; (3) B ultrasound or CT scan confirmed the peritoneal cavity to separate the impact of ascites and ascites estimates; (4) cardiac function III-IV grade; (5) ALT> 3 times the upper limit of normal and / or TBIL >2 upper limit of normal; (6) renal function is 3 and 3 above; (7) of the II degree and II than neutropenia, and / or moderate and moderate to severe anemia, and / or of the degree of thrombocytopenia II and II above; (8) The combined mental disorders.

Design outcomes

Primary

MeasureTime frame
Gastrointestinal malignant ascites;

Secondary

MeasureTime frame
Vascular endothelial growth factor;RBC ascites;Ascites tumor markers in the digestive tract;ECOG performance status;After the infusion of drug ascites drainage time , the number of drainage and drainage;

Countries

China

Contacts

Public ContactKaiwen Hu
kaiwenh@163.com+86 13911650713

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026